North America

Wellysis Secures FDA Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAI

Adds FDA-cleared AI analysis to Wellysis' S-Patch ECG monitoring solution, expanding its capabilities beyond ECG acquisition...

Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion, USP

The U.S. FDA has approved Lupin's Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD)...

ALZpath and Quanterix Expand Strategic Licensing Agreement to Advance Alzheimer's Disease Biomarker Research

Expanded Broadens Use of ALZpath's Proprietary pTau217 Antibody Technology across the Quanterix Simoa Research Portfolio...

Okami Medical Receives Expanded Indication for LOBO Vascular Occluder

LOBO's expanded indication brings venous embolization into the next generation, providing quick and confident occlusion ...

HAI Solutions Advances AI-Enabled IV Connector Care with New US Patent

QIKcap System: QIKcap is HAI Solutions' ultraviolet platform for needle-free IV connectors, built to support more consistent connector care in the hospital...

AIRS Medical Receives FDA Clearance for SwiftSight Body Composition

SwiftSight Body Composition is designed around a scan of less than five minutes, followed by automated AI analysis...

Aevice Health gains FDA clearance for AI-powered wheeze detection software

The Class II decision-support software analyses lung sound recordings from compatible FDA-cleared electronic stethoscopes and flags recordings suggestive of wheeze for clinical review....

Emboline Marks First US Commercial Use of Emboliner During TAVR

The Emboliner is designed to provide full-body embolic protection by capturing and removing debris generated during transcatheter structural heart procedures ...

Angelalign Introduces Pressure Points for More Predictable Tooth Movement

Pressure Points is the result of Angel's ongoing research initiatives, which concentrate on improving clinical predictability and effectiveness...

Healthcare Triangle, Inc Signs MOU to Bring AI-Enabled Humanoid Nursing Robots to Hospitals

The Proposed venture would deploy humanoid robots to assist with patient toileting and hygiene care, easing the physical burden on nursing teams while preserving patient dignity...